Recall Z-0199-2007 ยท KPA Slide Stainer, Automated
Dako Colorado, Inc.
Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431)
| Date | Nov 21, 2006 (initiated Oct 2, 2006) |
| Status | Terminated |
| Reason | Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis. |
| Root cause | Other |
| Action | Consignees were notified by phone on 10/02/2006 and later by letter on 10/20/2006. They were given the option of using the stainer as 'Research Use Only' or having the stainer returned to Dako. |
| Quantity | 11 units |
| Distribution | Worldwide distribution --- USA including states of CA, IN, NC, WA and countries of Denmark, France, Germany, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.